Lupin gets nod from USFDA for Mirabegron extended-release tablets

29 Sep 2022 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Mirabegron Extended-Release Tablets, 25 mg and 50 mg, to market a generic equivalent of Myrbetriq Extended-Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development, Inc. The product will be manufactured at Lupin’s facility in Nagpur, India.

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, (RLD Myrbetriq) had estimated annual sales of $2403 million in the U.S. (IQVIA MAT June 2022).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

Lupin Share Price

2121.65 -25.95 (-1.21%)
28-Jan-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1610.15
Dr. Reddys Lab 1224.30
Cipla 1328.25
Zydus Lifesciences 896.60
Lupin 2121.65
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×